Process Engineer, Cell Therapy Process Development

We are seeking a highly motivated Process Engineer to support late-stage cell therapy process development and characterization activities. In this role, you will play critical role in advancing late-stage cell therapy process development, process characterization, and BLA‑enabling studies. 
 
This position focuses specifically on cell therapy unit operations, including T-cell enrichment, activation, transduction, washes and harvest either semi-automated or fully automated equipment.  

The ideal candidate brings deep technical expertise, hands-on experience with cell therapy unit operations, and demonstrates success in supporting clinical and commercial readiness. 

Key Responsibilities 

Process development and characterization 

• Design, execute, and support autologous or allogenic cell therapy process optimization and robustness studies.   

• Drive implementation of closed-system operations and automation strategies to support scalability and compliance.  

• Plan and execute process characterization studies (DOE, multivariate studies, scale‑down models, and scale‑up assessments) in alignment with QbD and ICH guidelines. 

• Perform data analysis, write technical reports, and present outcome of the studies to cross‑functional teams and governance forums. 

• Conduct batch record review, deviation assessment, and data trending to ensure robustness of cell therapy manufacturing processes. 

• Apply AI‑enabled tools and digital analytics to accelerate data review, trend analysis, batch record evaluation, and process understanding. 

PPQ, Tech Transfer & Manufacturing Readiness 

• Provide on‑the‑floor technical support during scale‑up, engineering runs, PPQ batches, and commercial manufacturing campaigns (including off‑shift support when required). 

• Support raw material risk assessments, comparability studies, and process risk evaluations across facilities and platforms. 

Cross‑Functional Collaboration 

• Work closely with analytical sciences and manufacturing science and technology teams to ensure end‑to‑end process alignment. 

• Support lifecycle management, post‑approval changes, and continuous improvement initiatives for cell therapy processes. 

Qualifications 

• B.S. in Chemical Engineering, Biochemical Engineering, Biotechnology, or related field with 3+ years of hands‑on industry experience; OR M.S. with 2+ years; OR Ph.D. with 0 years of industry experience 

• Strong technical expertise in key cell therapy unit operations (e.g., cell isolation, activation, transduction, expansion, harvest, formulation, cryopreserv